Combination Chemotherapy and Bone Marrow Transplant in Treating Patients With Refractory or Recurrent Ovarian Cancer

NCT00002474 | Completed Phase 2

• 3 other identifiers: LUMC-3007CDR0000076845NCI-V91-0058
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, carboplatin, and mitoxantrone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy with autologous bone marrow transplant may allow the doctor to give higher doses of chemotherapy and kill more tumor cells. PURPOSE: This phase II trial is studying how well chemotherapy and autologous bone marrow transplant work in treating patients with refractory or recurrent ovarian cancer.

Conditions

Ovarian Cancer

Keywords

recurrent ovarian epithelial cancer

Outcome Measures

Primary Outcomes (4)

• Response rate

• Response duration

• Overall survival

• Nonhematopoietic toxicity

Interventions

carboplatin DRUG

cyclophosphamide DRUG

mitoxantrone hydrochloride DRUG

autologous bone marrow transplantation PROCEDURE

bone marrow ablation with stem cell support PROCEDURE

Eligibility Criteria

• Age: Up to 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Diagnosis of refractory or relapsed ovarian epithelial cancer * Must have failed prior regimen containing cisplatin or carboplatin * Bidimensionally measurable or evaluable disease * Serial CA-125 antigen titers or cytologically positive pleural effusion and/or ascites acceptable as evaluable disease * Autologous bone marrow harvest of greater than 1.2 x 10 to the eighth nucleated cells/kg required before study entry * No evidence of tumor at marrow harvest sites by bilateral bone marrow aspirates and biopsies, pelvic x-ray, and bone scan * CNS involvement allowed PATIENT CHARACTERISTICS: Age: * Under 65 Performance status: * SWOG 0-2 Life expectancy: * At least 8 weeks Hematopoietic: * WBC greater than 3,500/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 10.0 g/dL Hepatic: * Bilirubin less than 2.0 mg/dL * SGOT and SGPT less than 2 times upper limit of normal Renal: * Creatinine clearance greater than 60 mL/min * No prior hemorrhagic cystitis Cardiovascular: * LVEF greater than 45% by MUGA scan Other: * No hearing loss in voice tones * No active infection * No psychological contraindication to study treatment * Not pregnant * Negative pregnancy test * HIV negative * General medical condition must allow general anesthesia PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * No prior bone marrow transplantation * More than 4 weeks since other prior biologic therapy and recovered Chemotherapy: * See Disease Characteristics * More than 4 weeks since prior chemotherapy (at least 6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: * Not specified Radiotherapy: * More than 4 weeks since prior radiotherapy and recovered Surgery: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153-5500, United States

Location

Related Publications (2)

• Stiff PJ, Bayer R, Kerger C, Potkul RK, Malhotra D, Peace DJ, Smith D, Fisher SG. High-dose chemotherapy with autologous transplantation for persistent/relapsed ovarian cancer: a multivariate analysis of survival for 100 consecutively treated patients. J Clin Oncol. 1997 Apr;15(4):1309-17. doi: 10.1200/JCO.1997.15.4.1309.

  PMID: 9193322 RESULT

• Stiff P, Bayer R, Camarda M, Tan S, Dolan J, Potkul R, Loutfi S, Kinch L, Sosman J, Peace D, et al. A phase II trial of high-dose mitoxantrone, carboplatin, and cyclophosphamide with autologous bone marrow rescue for recurrent epithelial ovarian carcinoma: analysis of risk factors for clinical outcome. Gynecol Oncol. 1995 Jun;57(3):278-85. doi: 10.1006/gyno.1995.1143.

  PMID: 7774830 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Carboplatin; Cyclophosphamide; Mitoxantrone

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Quinones; Polycyclic Compounds

Study Officials

• Patrick J. Stiff, MD

  Loyola University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: February 1, 1991
• Study Completion: October 1, 2005
• Last Updated: May 30, 2013

Record last verified: 2003-03

Locations

US (1)